The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01073748
First received: February 22, 2010
Last updated: January 23, 2011
Last verified: January 2011
  Purpose

Asthma is a common inflammatory airway disease. Several researches have demonstrated a possible connection between asthma and exposure to paracetamol.

Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable change in lung functions.

This trial aims to identify a possible effect of single dose paracetamol on lower airway function.


Condition Intervention
Asthma
Drug: paracetamol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • A measurable change in lung functions in response to paracetamol exposure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: asthmatic subjects
Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
Drug: paracetamol
single dose of paracetamol 15mg/kg.
Other Names:
  • Acetaminophen
  • Acamol
Healthy children
Children with no asthma as control group.
Drug: paracetamol
single dose of paracetamol 15mg/kg.
Other Names:
  • Acetaminophen
  • Acamol

Detailed Description:

Asthma is a common inflammatory airway disease and its prevalence is on the rise all around the world, Most significantly in children under 5 years.

Paracetamol is one of the most common drugs used with children at thus age groups and several studies have proved a causative connection between exposure to paracetamol and asthma prevalence as well as other allergic conditions.

The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst and formation of reactive oxygen species (ROS).

In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.

The goal of this research is to identify and quantify the effect of single dose of paracetamol on lung functions of asthmatic and healthy subjects.

The study group will include 40 children aged 7-16 years, who are known to have asthma and a control group of 20 healthy children.

The children will be randomized to receive a dose of paracetamol or placebo, and lung functions will be measured by both spirometry and Fraction of expired Nitric Oxide (FeNO) test.

Each child will receive both paracetamol and placebo, randomly in to consecutive tests, thus children will serve as their own control.

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age: 7-16 years
  • research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria
  • control group: children who are not known to have asthma

Exclusion Criteria:

  • paracetamol sensitivity
  • children with any kind of chronic disease (except asthma)
  • children with non asthma related chronic lung disease
  • acute asthma attack
  • children on systemic steroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073748

Contacts
Contact: Ruth Soferman, M.D 972-3-6975691 ruthso@tasmc.health.gov.il
Contact: Assaf Tsivion, M.D 972-52-7360333 assaft@hotmail.com

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Sub-Investigator: Assaf Tsivion, M.D         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ruth Soferman, M.D TASMC
  More Information

No publications provided

Responsible Party: Dr. Ruth Soferman, Tel-Aviv Sourasky Medical Center, Israel, Tel-Aviv Sourasky Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01073748     History of Changes
Other Study ID Numbers: TASMC-10-RS-422-CTIL
Study First Received: February 22, 2010
Last Updated: January 23, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Asthma
Acetaminophen
paracetamol
FeNO
Spirometry
Lung function

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014